Two Important Approvals for Dermal Rejuvenation Clinical Trial Received by RepliCel Life Sciences

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VANCOUVER, BC – July 21, 2015 – RepliCel Life Sciences Inc. (OTCQB: REPCF)(TSX.V: RP),
a clinical stage regenerative medicine company focused on the
development of autologous cell therapies, today announced it has
received two important approvals required to conduct its RCS-01 phase 1
human clinical trial. The first is from the Ethics Committee of the
Faculty of Medicine Heinrich-Heine Universität Duesseldorf, a criteria
for clinical trial initiation, and the second is approval from the
Leibniz-Institut for its Tissue Procurement Authorization (TPA). Ethics
Committee approval and TPA are two parts of a three-part Clinical Trial
Application (CTA) approval process required to conduct human clinical
trials in Germany. The final approval required is from the Paul Ehrlich
Institute (PEI), the German regulatory body. If cleared to proceed, the
proposed trial will be conducted at the IUF Leibniz-Institut für
umweltmedizinische Forschung GmbH in Germany.

RepliCel’s non-bulbar dermal sheath-derived fibroblast therapy
entitled RCS-01 provides a promising treatment for intrinsically or
extrinsically aged/damaged skin by providing UV-naïve collagen-producing
cells directly to affected areas. RepliCel’s unique manufacturing
technology allows for isolation of fibroblasts derived from anagen-hair
follicle mesenchymal tissue, which elicit more efficient replication
potential in culture. Furthermore, the proprietary culture conditions in
which RCS-01 is manufactured enables these cells to maintain
plasticity. This plasticity allows the cells to adapt to the
microenvironment and respond to the mechanical or surrounding stimuli
after injection, leading to robust production of type 1 collagen and
elastin and their proper alignment within the tissue. For more
information on this trial, please visit www.clinicaltrials.gov.

“The market for dermal fillers currently represented almost 6 million
procedures and expenditures of almost $2 billion in 2013 according to
statistics provided by the American Society of Plastic Surgeons. RCS-01
could disrupt this market by providing patients with a filler comprised
of their own fibroblast cells – a much more compelling long-term
solution than hyaluronic acid which dissipates in approximately six
months,” commented Dr. Rolf Hoffmann, Chief Medical Officer.
“Successfully treating aged and sun damaged skin with our therapy would
allow a patient to have a renewed dermal appearance by repopulating the
patient’s aged and depleted fibroblast cells which are the key cells
responsible for maintaining and repairing the skin’s extracellular
matrix.”

“These two important approvals bring us closer to initiation of our
RCS-01 clinical trial. Approval from the PEI will enable us to
immediately begin the recruitment phase of our trial. With the
initiation of this study, we will have two clinical trials using our
NBDS-fibroblasts underway; RCT-01 in Canada and RCS-01 in Germany,”
stated David Hall, CEO.

Trial Design
The study is anticipated to include 30 participants (24 treated, 6
placebo), male and female, who will receive either an injection of
RCS-01 or placebo (on a 4:1 treatment-to-placebo ratio). The primary
purpose of this study is to assess the safety profile of RCS-01
injections compared to placebo injection at 6 and 12 months. The study
will also measure the impact these injections will have on skin markers
related to aging through evaluation of gene expression profiles at 3 and
6 months. 16 participants will be biopsied for gene expression of skin
aging markers and 12 participants biopsied for histopathology analysis
to assess structural characteristics and molecular markers associated
with skin aging. This trial design is intended to deliver biologic data
related to how, and the degree in which the product injection improves
the fullness of the extracellular matrix supporting the skin. This data
will be critical to designing future trials intended to affect the
skin’s appearance in areas of aesthetic importance.

About Aging Skin
The dermis and epidermis components of the skin lose thickness with age.
Solar radiation, particularly UVA, is known to penetrate deep into the
dermal layer, damaging fibroblasts, which are the major cellular
component of the dermis. Similarly, there are some studies reporting
that air pollutants/nanoparticles may also penetrate transepidermally,
negatively impacting the dermal layer. The damage caused by external
stimuli include DNA strand breaks and mutations, which, if not repaired
properly, can lead to cell death. Similarly, oxidative stress caused by
smoking leads to not only damages to DNA but also to other cellular
components such as proteins and lipids. Accumulation of damages to
cellular proteins and DNA from years of exposure to extrinsic insults
can lead to physiological changes to the skin that are
naturally-irreversible. Such changes are often associated with reduction
in fibroblasts, disorganization of collagen fibrils and decreased
production of collagen, elastin and other glycoproteins that provide
structural support and stability to the extra cellular matrix “ECM”
network. Such changes to the dermal components are detrimental to
maintaining mechanical tensile ability and structural integrity of the
skin.

About RepliCel Life Sciences

RepliCel is a regenerative medicine company focused on developing
autologous cell therapies that address diseases caused by a deficit of
healthy cells required for normal healing and function. The company’s
RCT-01, RCS-01, and RCH-01 cell therapies are designed to treat chronic
tendinosis, damaged or aging skin, and pattern baldness. All product
candidates are based on RepliCel’s innovative technology utilizing cell
populations isolated from a patient’s own healthy hair follicles. The
company is also developing a propriety injection device optimized for
the administration of its products and licensable for use with other
dermatology applications. The company’s product pipeline is comprised
of multiple clinical trials anticipated to launch through Q1 2015 in
addition to Shiseido’s own clinical trial of RCH-01 and the device in
late prototype development. Visit www.replicel.com for additional information.